Cell and Gene Therapy Manufacturing Services Market
Number of pages: 100 | Report Format: PDF | Published date: April 06, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 6.5 billion |
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Revenue Forecast in 2031 |
US$ 23.8 billion |
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CAGR |
15.4% |
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Base Year For Estimation |
2022 |
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Forecast Period |
2023-2031 |
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Historical Year |
2021 |
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Segments Covered |
Type, Indication, End User, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global cell and gene therapy manufacturing services market was valued at US$ 6.5 billion in 2022 and is expected to register a revenue CAGR of 15.4% to reach US$ 23.8 billion by 2031.
Cell and Gene Therapy Manufacturing Services Market Fundamentals
Cell and gene therapies significantly advance patient care by treating or possibly curing a wide range of diseases previously untreatable by small molecule and biological medicines. These therapies have the potential to transform medicine and improve patient outcomes considerably. However, there are still obstacles to overcome, such as high prices and the requirement for specialized infrastructure and expertise. Over the last two decades, the FDA has authorized more than 20 cell and gene therapies, with many of these one-time therapies costing between $37,500 to $2 million per shot. Despite the high costs of cell and gene therapy manufacturing, they are cost-effective in the long run by decreasing the need for ongoing treatments and hospitalizations.
Furthermore, ongoing research and development may lead to more affordable patient options. Given the high financial investment and patient expectations for these life-saving pharmaceuticals, manufacturers must provide integrated services across the entire supply chain to allow efficient biomanufacturing processes, smooth logistics, and minimize uptake barriers. Furthermore, manufacturers must collaborate closely with payers and regulators to develop reasonable pricing and reimbursement models that guarantee patient access while ensuring the healthcare system's long-term viability.
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Cell and Gene Therapy Manufacturing Services Market Dynamics
Many biopharma companies have re-invested in research and development to standardize vector manufacturing and purification, use forward engineering methods in cell therapies, improve cryopreservation of cellular samples, and investigate the development of off-the-shelf allogeneic cell solutions. Companies are now carefully reviewing their in-house capabilities and investing in their production facilities or outsourcing to contract development and manufacturing organizations (CDMOs) to increase their manufacturing capabilities.
The investment in cell and gene therapy clinical trials has recently increased dramatically due to a rise in demand for novel medicines to address unmet medical requirements. According to the 2018 PhRMA report on the cell and gene therapy pipeline, biopharmaceutical firms had 289 cell and gene therapies in clinical research, with 362 cell and gene therapies in clinical research by 2020. This cell and gene therapy pipeline expansion is expected to continue in the coming years, with many therapies receiving regulatory clearance and entering the market. These novel therapies can potentially transform the treatment of various illnesses, including cancer, genetic disorders, and rare diseases, the most important cell and gene therapy manufacturing services trend.
However, there are numerous challenges in development, including safety and efficacy issues, lengthy clinical study procedures, stringent regulatory frameworks, and high cell and gene therapy prices. The ability to treat heterogeneous systems with a variety of cells simultaneously, high gene transfer efficiency, low cell toxicity, and single-cell specificity to the intended target are some of the important elements. Several CAR T-cell therapies have been approved, but according to WHO statistics, one in every five eligible cancer patients dies while waiting for a manufacturing facility. Previously, many of these autologous products required about a month to produce; however, some can now be produced in less than two weeks.
Cell and Gene Therapy Manufacturing Services Market Ecosystem
The global cell and gene therapy manufacturing services market is analyzed from four perspectives: type, indication, end user, and region.
Cell and Gene Therapy Manufacturing Services Market by Type
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Based on the type, the global cell and gene therapy manufacturing services market is segmented into cell therapy and gene therapy. The cell therapy segment is further sub-segmented into an allogeneic, autologous, and viral vector. Also, the gene therapy segment is further divided into non-viral and viral vectors.
The gene therapy segment accounted for the largest revenue share of the global cell and gene therapy manufacturing services market in 2022. The science of gene therapy is approaching a tipping point. With a recent surge in clinical activity, it is primed for further expansion. Gene therapy has shown encouraging results in the treatment of genetic disorders and cancer, and future research should lead to the creation of more effective and safe therapies. However, there are still issues to address, such as the high cost of therapy and the possibility of long-term side effects. With investigational new drug (IND) applications with the FDA for ongoing gene therapy clinical studies and several novel gene therapy indications expected to win U.S. and Europe market approval by 2030, the field is poised to grow exponentially.
Furthermore, scientific and technological advancements will increase the number of therapies accessible, allowing them to reach more people and cure more common diseases. The ability to introduce inhibition into disease pathways via gene therapy, thereby blocking some dysregulated functions during the disease, will be a breakthrough for the market to move beyond genetic diseases and into chronic diseases that affect wider populations. Gene therapy's success in treating rare genetic illnesses has cleared the way for its potential use in treating more common chronic diseases like heart disease and diabetes. More research is required, however, to fully understand the long-term effects and safety of gene therapy in these larger populations.
Allogeneic therapies use a unique source of cells to treat many patients. They raise the danger of inducing an immune reaction in the patient, and immunosuppressive therapies are sometimes used in conjunction with allogeneic products. As a result, rising physician interest in the therapeutic use of allogeneic therapies and rising knowledge about the use of cord cells and tissues across various therapeutic areas are major factors driving revenue growth. Allogenic cells have advantages because they generate immune stem cells that kill cancer cells that persist even after high-dose cytotoxic drug treatment. The main drivers of market revenue growth are growing awareness of allogeneic cell therapy, increased funding for new cell lines, increased partnerships and acquisitions, and the creation of advanced genomics methods.
Cell and Gene Therapy Manufacturing Services Market by Indication
Based on the indications, the global cell and gene therapy manufacturing services market is segmented into oncology, cardiovascular, orthopedic, infectious, neurological, and other indications.
The oncology diseases segment accounted for the largest revenue share of the global cell and gene therapy manufacturing services market in 2022. The broad field of cell and gene therapy offers several novel treatments likely to play an important role in cancer prevention. Using modified viruses to deliver therapeutic genes directly to cancer cells is one of the most promising gene therapy methods. This technique has shown great promise in early clinical trials and may give a more specific means to target cancer cells than traditional chemotherapy or radiation therapy. Oncology cell and gene therapy manufacturing concentrates on clinical evaluations of transformative cancer therapies based on cutting-edge technologies with curative promise and aids in their development.
Cell and Gene Therapy Manufacturing Services Market by End User
Based on the end users, the global cell and gene therapy manufacturing services market is segmented into pharmaceutical and biotechnology companies, academic and research institutes, and other end users.
The pharmaceutical and biotechnology companies segment accounted for the largest revenue share of the global cell and gene therapy manufacturing services market in 2022. Many biopharma companies are cautiously investing in cell and gene therapy. The high costs and uncertainties in developing and commercializing new therapies account for this circumspect strategy. However, it is a promising area for investment due to the potential for a transformational effect on patient outcomes. The bulk manufacturing processes used for conventional medicines are incompatible with cell and gene therapy. Traditional pharmaceutical manufacturing techniques concentrate on producing high-quality made-to-order bulk products that are distributed in large amounts to various patients. The volume of bulk manufacturing depends on market demand and typically takes more than a year to finish. Cell and gene therapy manufacturing services in pharmaceutical and biotechnology companies are trending owing to the fast development and manufacture of advanced cell and gene therapies.
Cell and Gene Therapy Manufacturing Services Market by Region
The global cell and gene therapy manufacturing services market is segmented based on the region into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for the largest revenue share of the global cell and gene therapy manufacturing services market in 2022. The growth of the regional market as a whole is being driven to a large extent by an increase in research and development activities and a supportive healthcare infrastructure. The expansion of the healthcare sector in the area is also being fueled by the rising demand for cutting-edge medical technology and the rising incidence of chronic illnesses. These factors are expected to fuel the market revenue growth during the forecast period.
Competitive Landscape of the Global Cell and Gene Therapy Manufacturing Services Market
Companies are expected to benefit from increased investment and funding for cell and gene therapy advancements. Furthermore, major players are engaged in strategic initiatives to improve their market offerings, which is expected to boost cell and gene therapy manufacturing competition during the forecast period. The growing demand for innovative technologies and the adoption of automation in various industries are also driving market development. Furthermore, the rising trend of Industry and the integration of artificial intelligence with robotics are anticipated to fuel market revenue growth in the near future. Major market players operating in the global market with the largest market revenue share are:
Strategic Development in Cell and Gene Therapy Manufacturing Services Market
Cell and gene therapy services entail the delivery of genetic material, typically in the form of a carrier or vector, the incorporation of the gene into the proper bodily cells, and includes the introduction of cells into the patient with the appropriate function.
Increasing acceptance of cell and gene therapy with respect to emerging chronic diseases is the most important factor driving market revenue growth.
High costs and the need for more awareness about cell and gene therapy manufacturing services are potentially restricting the revenue growth of the global market.
The gene therapy segment accounted for the largest revenue share of the global cell and gene therapy manufacturing services market.
Key companies operating the global cell and gene therapy manufacturing services market are Lonza Group, Bluebird Bio Inc., Catalent Inc., F. Hoffmann-La Roche Ltd., and Samsung Biologics.
The global cell and gene therapy manufacturing services market is expected to grow at a revenue CAGR of 15.4% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain